HOPE At Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System
XVIVO Perfusion
20 participants
Aug 3, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death. The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System. The secondary objectives are to evaluate patient outcomes and graft function post-transplant.
Eligibility
Inclusion Criteria3
- Age ≥18 years
- Signed informed consent form
- Accepted and/or listed for heart transplantation
Exclusion Criteria8
- Not able to understand the information provided during the informed consent procedure
- Previous solid organ transplantation
- Grown-up congenital heart disease
- Dialysis
- Incompatible blood group
- Combined organ transplantation candidates
- Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
- Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)
Interventions
Direct procurement of donor hearts from DCD donation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06485596